Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors

By Marcelo Trevino, independent expert

The European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) impose stringent requirements on all economic operators involved in the supply chain of medical devices. Among these requirements, Article 16 of both MDR and IVDR specifically addresses the obligations of importers and distributors who engage in relabeling and repackaging activities.

As these activities can significantly impact regulatory compliance, importers and distributors must obtain Article 16 certification from a notified body (NB) to ensure that their quality management system (QMS) meets the EU’s regulatory requirements. This article explores the key aspects of Article 16 certification, including its scope, obligations, qualifying activities, and the certification process.

MDCG 2021-23 Guidance

The MDCG 2021-23 guidance provides specific clarification on how economic operators, including importers and distributors, should comply with Article 16 of MDR and IVDR. This guidance outlines best practices for ensuring compliance when performing relabeling or repackaging activities, emphasizing quality system requirements, traceability measures, and risk management. It also provides structured templates for notifying competent authorities and manufacturers, ensuring transparency in the supply chain.

The guidance ensures that importers and distributors take accountability for their modifications to devices, requiring them to adhere to strict documentation, traceability, and quality assurance practices. It further clarifies the technical documentation required, including proof that relabeling and repackaging activities do not compromise the original integrity and performance of the device. Notably, the MDCG 2021-23 guidance sets forth the expectation that importers and distributors implement post-market surveillance activities, including the ability to trace any changes made to a device throughout its distribution cycle.

Understanding Article 16: Scope And Obligations

Article 16 of MDR and IVDR sets specific regulatory obligations for importers and distributors when they perform the following activities:

1. Translating labeling, instructions for use (IFUs), or other documentation to make the device compliant with local market language requirements
2. Repackaging to meet national packaging regulations, which may include breaking down bulk packaging into smaller units
3. Adding necessary details to product labeling to meet local regulatory requirements while ensuring device integrity

While these activities do not change the fundamental nature or intended use of the device, they introduce risks that require quality management oversight. To address these risks, importers and distributors performing relabeling and repackaging must obtain an Article 16 certification from a notified body to demonstrate compliance with quality and safety requirements.

Who Exactly Needs Article 16 Certification?

Not all importers and distributors require Article 16 certification. It is specifically mandatory for companies that:

• modify packaging or labeling of a medical device after it has been placed on the EU market
• translate the IFUs or product labeling to meet national language requirements
• repackage bulk medical devices into smaller units for sale
• perform any of the above activities independently, without being under the direct control of the legal manufacturer.

Companies DO NOT need Article 16 certification if:

• they operate within the manufacturer's established ISO 13485-certified QMS
• they only distribute devices without modifying labeling or packaging
• they are health institutions repackaging devices only for internal use (for example, hospitals breaking bulk packaging for in-house supply).

Key Requirements For Article 16 Certification

For importers and distributors to obtain Article 16 certification, they must establish and maintain a robust QMS that meets the regulatory requirements outlined under the MDR and IVDR. The QMS must cover key operational areas, ensuring compliance with documentation, supplier management, facility standards, corrective actions, and traceability. Below is a summarized explanation of the most critical requirements that need proper oversight from importers and distributors.

Documentation & Record Keeping: A well-structured documentation system is fundamental for compliance. Importers and distributors must ensure the following:

• Detailed Records of Relabeling and Repackaging Activities
  • Maintain accurate and comprehensive records of any modifications made to medical devices, including changes to labeling, IFUs, or repackaging activities.
  • Record the batch or lot number, the date of modification, and the individual or team responsible for the changes.
  • Maintain records for at least 10 years post-market placement (15 years for implantable devices), as required under MDR and IVDR.
• Procedures for Document Control and Version Tracking
  • Implement a document control system to manage revisions of regulatory documents, ensuring that only the latest approved versions are in use.
  • Establish an approval workflow for document changes, including sign-offs from quality and regulatory personnel.
  • Conduct periodic audits to verify compliance with document control policies.

Supplier & Subcontractor Management: Importers and distributors must ensure stringent oversight of their supply chain partners, particularly if third-party subcontractors are involved in relabeling or repackaging activities. Importers and distributors must ensure the following:

• Procedures for Selecting and Managing Subcontractors
  • Develop a supplier qualification process, ensuring that subcontractors adhere to ISO 13485 and MDR/IVDR requirements.
  • Perform due diligence when selecting subcontractors, requiring them to provide documentation proving regulatory compliance.
  • Establish legally binding quality agreements with subcontractors outlining roles, responsibilities, and compliance obligations.
• Supplier Qualification and Monitoring Processes
  • Conduct supplier audits to assess compliance with regulatory and quality standards.
  • Monitor supplier performance using key performance indicators (KPIs), including defect rates, compliance audit results, and corrective action response times.
  • Implement a supplier risk assessment program, categorizing vendors based on potential regulatory and operational risks.

Resource & Facility Management: Facilities involved in relabeling and repackaging must meet stringent quality standards to prevent contamination, labeling errors, and non-compliance risks. Importers and distributors must ensure the following:

• Adequate Facilities for Relabeling and Repackaging
  • Establish dedicated repackaging areas with controlled environmental conditions to ensure product integrity.
  • Conduct routine facility inspections to verify compliance with GMP (good manufacturing practices) guidelines.
  • Implement training programs for staff involved in repackaging, emphasizing adherence to regulatory and quality standards.
• Cleanroom Standards (If Applicable for Sterile Devices)
  • If handling sterile medical devices, facilities must meet ISO 14644 cleanroom classifications, ensuring particle contamination control.
  • Maintain air filtration systems (HEPA/ULPA filters) to reduce microbial contamination risks.
  • Establish validated sterilization procedures if sterilization is required post-repackaging.

Corrective & Preventive Actions (CAPA) and Post-Market Surveillance: Ensuring compliance with manufacturer corrective actions and implementing preventive mechanisms is critical for regulatory success. Importers and distributors must ensure the following:

• Compliance with Manufacturer Corrective Actions
  • Maintain open communication with the legal manufacturer of the device to receive and implement any required corrective actions.
  • Ensure compliance with field safety corrective actions (FSCAs) and recall management procedures as mandated by the manufacturer and regulatory authorities.
• Mechanisms to Address Non-Conforming Devices and Recalls
  • Establish a non-conformance reporting (NCR) system to track and investigate deviations from regulatory or quality standards.
  • Implement root cause analysis (RCA) for recurring issues and initiate corrective and preventive actions.
  • Maintain a recall response plan, outlining steps to remove non-compliant products from the market efficiently.

Traceability & Labeling Compliance: Traceability ensures that all repackaged and relabeled products can be tracked back to their original manufacturer, reducing risks of mislabeling or counterfeit products. Importers and distributors must ensure the following:

• Full Traceability of All Repackaged and Relabeled Products
  • Implement UDI (unique device identification) tracking for all modified devices, ensuring compliance with MDR/IVDR traceability requirements.
  • Maintain records of all labeling and repackaging activities, including product origin, batch number, and distribution information.
  • Utilize electronic batch records (EBRs) and inventory management systems to facilitate accurate tracking and recall processes.
• Ensuring Consistency of Labeling with Original Manufacturer Specifications
  • Follow manufacturer guidelines to ensure no deviations in labeling content that could mislead users or affect device performance.
  • Conduct label verification checks before product distribution, ensuring accurate translations and regulatory compliance.
  • Implement bar code scanning or serialization techniques to ensure labels match product specifications accurately.

A well-implemented QMS ensures that importers and distributors maintain regulatory compliance, patient safety, and product integrity. By adhering to strict documentation, supplier oversight, facility controls, corrective actions, and traceability standards, companies can successfully achieve Article 16 certification and gain approval from notified bodies.

It is important to note that importers and distributors must notify the competent authority and the legal manufacturer at least 28 days before placing a relabeled/repackaged device on the market and provide sample labels or packaging upon request.

5-Step Certification Process

The certification process for Article 16 compliance involves five steps, ensuring that importers and distributors meet the EU regulatory standards.

1. Initial Inquiry & Application: Submit an inquiry to a notified body (NB) and receive a pre-application review and quotation from the NB.
2. Quality System Assessment: The NB audits the importer/distributor’s QMS and documentation is reviewed for compliance with MDCG 2021-23 guidance.
3. Audit & Compliance Check: On-site audits are conducted to verify proper labeling, packaging, and document control procedures, and auditors ensure full traceability and supplier oversight mechanisms are in place.
4. Certification Decision: Upon successful completion, the Article 16 certificate is issued. The certification is valid for three years, with annual surveillance audits.
5. Ongoing Compliance & Renewal: Annual QMS audits are required in Year 1 and Year 2 and a full recertification audit is performed in Year 3. Importers and distributors shall always ensure continued compliance with any regulatory updates.

Pitfalls To Avoid: Common Challenges & Compliance Risks

Despite clear regulatory guidelines, companies often face challenges in achieving Article 16 certification, including:

• Inadequate Documentation: Some importers and distributors fail to maintain detailed records of relabeling and repackaging activities. This can lead to non-compliance findings during audits, as regulators require proof that modifications do not compromise device integrity. To mitigate this risk, companies should implement electronic documentation systems with automated version tracking and ensure regular internal audits.
• Supply Chain Complexity: Many importers and distributors rely on third-party subcontractors for relabeling and repackaging, which can create compliance risks if suppliers do not adhere to MDR/IVDR standards. Companies must establish strict supplier qualification procedures, conduct routine audits, and include legally binding quality agreements to ensure accountability and regulatory compliance.
• Regulatory Misinterpretation: Misunderstanding the distinction between modifications requiring manufacturer approval versus those necessitating Article 16 certification can lead to non-compliance. Importers and distributors should invest in regulatory training for quality and compliance teams and engage subject matter experts when unsure about specific requirements.
• Delayed Notifications: Some companies fail to notify competent authorities and manufacturers at least 28 days before placing relabeled or repackaged devices on the market. This can result in delays or penalties. Implementing a compliance calendar with automated alerts can help ensure timely notifications and avoid regulatory issues.

Conclusion

Under Article 16(2) of the MDR and IVDR, importers and distributors that engage in relabeling or repackaging of devices already placed on the EU market must obtain an Article 16(4) certificate from the Competent Authority of the EU Member State where the modified device will be made available. Those requiring an Article 16(4) certificate must apply for the Article 16(4) Certification Scheme through a notified body designated for the specific types of devices subject to relabeling or repackaging. Additionally, importers and distributors must implement a QMS that includes documented procedures to ensure compliance with the requirements set out in Article 16(3).

For importers and distributors seeking Article 16 certification, adherence to strict quality and regulatory standards is critical. By ensuring compliance with MDR and IVDR requirements, companies can:

• secure uninterrupted access to the EU market
• avoid regulatory penalties and product recalls
• establish robust post-market surveillance mechanisms
• strengthen trust with legal manufacturers and regulatory bodies.

To streamline compliance, it is important for importers and distributors to:

• engage with a notified body early to understand certification requirements
• invest in QMS enhancements for better traceability and compliance
• conduct internal audits before official notified body assessments
• stay updated on evolving EU MDR/IVDR requirements to ensure continuous compliance.

Article 16 certification serves as a critical regulatory safeguard ensuring that importers and distributors uphold quality and safety standards for medical devices in the EU. As notified bodies continue accepting applications, companies must proactively ensure compliance to facilitate smooth market entry and long-term success in the European medical device market.

About The Author:

Marcelo Trevino has more than 25 years of experience in global regulatory affairs, quality, and compliance, serving in senior leadership roles while managing a variety of medical devices: surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, medical imaging/surgical navigation, in vitro diagnostic devices, and medical device sterilization and disinfection products. He has an extensive knowledge of medical device management systems and medical device regulations worldwide (ISO 13485:2016, ISO 14971:2019, EU MDR/IVDR, MDSAP). He holds a BS in industrial and systems engineering and an MBA in supply chain management from the W.P. Carey School of Business at Arizona State University. Trevino is also a certified Medical Device Master Auditor and Master Auditor in Quality Management Systems by Exemplar Global. He has experience working on Lean Six Sigma Projects and many quality/regulatory affairs initiatives in the U.S. and around the world, including third-party auditing through Notified Bodies, supplier audits, risk management, process validation, and remediation. He can be reached at marcelotrevino@outlook.com or on LinkedIn.